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IRCT20130211012438N30 IRCT 2019-02-19 Kashan University of Medical Sciences The effect of probiotic capsule on patients with macular degeneration associated with age Evaluation of the effects of capsules containing probiotics on metabolic parameters, oxidative stress and clinical symptoms of age-related macular degeneration 2018-05-20 anticipated 70 Complete https://irct.ir/trial/30157 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Blocks (one per group): Patients will be divided into two groups, probiotic (case) and placebo (control ). The division of selected subjects will be done randomly in blocks of study using quadrilateral blocks. The division of selected subjects will be done in randomized blocks using six rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). probiotic capsule (A) and placebo group (B). In this way, different scenarios are written on six cards and will be thrown into a bag and 60 cards will be written out of the bag for 15 times, and the order will be written in a sheet, Blinding description: Drugs and placebo are in the same packaging at the Barij Essence pharmaceutical company . Only the code is written on the packages. Patients and physician do not know the type of drug and after analyzing the data, packet codes are decoded. 3 Age-related macular degeneration. Intervention 1: Intervention group: probiotic capsule 500 MG,produced in tak gene company,One number per day for 2 months orally. Intervention 2: Control group: placebo capsule500 MG, produced in Tak gene company, ,One number per day for 2 months orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information
public Hasan Farajipoor
Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5554 0021 farajipoor_h@kaums.ac.ir Kashan University of Medical Sciences scientific mMohsen Taghizadeh
Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8719675537 +98 31 5533 3213 taghizadeh_m@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Reduced vision simply because of AMD 50 years 85 years Both Corneal opacity Diabetes History of retinal vascular disorders History of retina tear History of penetrating trauma H35.3 Degeneration of macula and posterior pole Treatment - Drugs Placebo Intervention group: probiotic capsule 500 MG,produced in tak gene company,One number per day for 2 months orally. Control group: placebo capsule500 MG, produced in Tak gene company, ,One number per day for 2 months orally. High sensitive-Critical Reactive Protein. Timepoint: At the beginning of the study and2 months after the start of the study. Method of measurement: ELISA. Visual Acuity. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Visual Acuity check with Snellen chart. Macular thickness. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Central Macular Thickness Evaluate with OCT Instrument. Fasting plasma glucose. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Enzymatic Kits. Triglycerides. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Enzymatic Kits. Low density lipoprotein-cholesterol. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Enzymatic Kits. High density lipoprotein-cholesterol. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Enzymatic Kits. Total cholesterol. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Enzymatic Kits. Very low density lipoprotein-cholesterol. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Standard formula. Nitric oxide. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Photospectrometry. Malondialdehyde. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Photospectrometry. Glutathion. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Photospectrometry. Total Anti Oxidant. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Photospectrometry. Insulin. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: ELISA. QUICKI. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Standard formula. HOMA-IR. Timepoint: At the beginning of the study and 2 months after the start of the study. Method of measurement: Standard formula. Kashan University of Medical Sciences Approved 2017-12-11 Ethics committee of kashan university of medical sciences Kashan University of Medical Sciences,Qotbe Ravandi Boulevard, Kashan kashan Isfehan Iran (Islamic Republic of)